FDA Approves New Pill for Endometriosis Pain



FDA Approves New Endometriosis Treatment Drug

This pill, Orilissa (elagolix), may be available by the end of summer 2019.

By Beth Levine

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FDA headquarters are located in White Oak, Maryland.
FDA headquarters are located in White Oak, Maryland.
Al Drago/Getty Images

July 24, 2019

Soon there will be another treatment option for women experiencing symptoms of endometriosis. Today the U.S. Food and Drug Administration (FDA) announced their approval for AbbVie to market the drug Orilissa (elagolix) in the United States for use in treating pain caused by endometriosis. Taken as a daily pill, the drug should be available in pharmacies as soon as early this August.

The drug is made by AbbVie in partnership with Neurocrine Biosciences.

Endometriosis is a chronic estrogen-dependent disease in which the uterine lining grows outside the uterus, usually on the ovaries, fallopian tubes, and surrounding tissue, causing severe pain, heavy bleeding, lesions, and sometimes issues with fertility. The (ACOG) estimates that endometriosis affects about 1 in 10 women of reproductive age in the United States.

RELATED: Endometriosis Symptoms and Diagnosis

A Welcome New Way to Help Ease Endometriosis Symptoms

There is currently no cure for endometriosis, so medical care has focused on pain reduction. AbbVie announced that elagolix is the first oral gonadotropin-releasing hormone (GnRH) antagonist developed for women with moderate to severe endometriosis pain. It is also the first new medical treatment option for endometriosis pain brought to market in a decade.

How the Drug May Work to Reduce Painful Symptoms

The pituitary gland releases gonadotropins, hormones that stimulate production of gonadal steroids such as estrogen, both of which exacerbate symptoms of endometriosis and uterine fibroids. The GnRH-antagonist activity of elagolix reduces gonadotropin levels, which in turn suppresses estradiol, a type of estrogen. This minimizes the pain associated with endometriosis and the spread of lesions.

Overall, the drug has been studied in more than 40 clinical trials with more than 3,000 subjects. Clinical phase 3 trials looked at approximately 1,700 women with moderate-to-severe endometriosis pain. Results showed that the drug significantly reduced the three types of pain caused by endometriosis: daily menstrual pelvic pain, nonmenstrual pelvic pain, and painful intercourse. Side effects were minimal.

RELATED: Want to Ease Endometriosis Pain and Other Symptoms? Don’t Forget to Address Your Stress Level

Leena Nathan, MD, an assistant clinical professor at the department of ob-gyn at UCLA Health, is looking forward to seeing the drug come to market. She explains that it works by shutting down the pituitary hormone formation so there is less estrogen circulating in the system. “It puts women into a premature menopause as long as the medication is taken. You reduce endometriosis symptoms, which is dependent on the hormonal cycle,” she says.

Potential Benefits of the Pill Delivery Method

Dr. Nathan adds that the treatment is in oral form instead of by injection, a bonus. “That makes it easily reversible. If the patient can’t tolerate the side effects, the effects wear off quickly after a day or two of stopping the drug. This is as opposed to a shot, which will last for one to three months. It’s also dose dependent, so you can get away with a lower dose, because we always worry about other issues such as bone loss and hot flashes with these kinds of medications.”

Helpful but Not a Cure: Some Experts Call for Cautious Optimism

Not every endometriosis specialist is ready to get on board just yet. Tamer Seckin, MD, a board-certified gynecologist and laparascopic surgeon in private practice at Seckin Endometriosis Center in New York City and the cofounder of the Endometriosis Foundation of America, says, “We have been fooled so many times until now. Elagolix might manage symptoms of endometriosis, but it’s not going to be the magic cure-all that everyone is expecting. It is not going to treat the actual disease. Gold standard treatment is early diagnosis and properly timed excisional removal of the disease. I am cautiously optimistic.”

Elagolix is also being studied for treatment of uterine fibroids, but it has not gained approval for that application yet.






Video: FDA Approves Orilissa For Endometriosis

FDA Approves New Endometriosis Treatment Drug
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2019 year - FDA Approves New Endometriosis Treatment Drug pictures

FDA Approves New Endometriosis Treatment Drug recommendations
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FDA Approves New Endometriosis Treatment Drug FDA Approves New Endometriosis Treatment Drug new pics
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Date: 10.12.2018, 14:18 / Views: 65332